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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:205777

GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes

Official recall number

Z-1179-2024

Evidence summary

Product code
FGE
Recall status
Open, Classified
Event initiated
January 19, 2024
Root cause
Packaging process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1179-2024

Field note

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